SIR-Spheres V-Vial Holder

Basic Information

• Brand Name: SIR-Spheres V-Vial Holder
• Primary DI: 00850014612078
• Version / Model: SIR-H001
• Company Name: SIRTEX MEDICAL PTY LTD
• Labeler DUNS: 755092467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-14
• Public Version: 2
• Public Version Date: 2022-01-19
• Public Version Status: Update
• Public Device Record Key: 11eb9f1f-bf71-481a-9ffa-06c36fab1392

Device Description

SIR-Spheres V-Vial Holder

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWW	Shield, Vial	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38380	Vial radiation shield	A device, sometimes called a vial holder, designed to partially or completely surround a vial or a container of a solid or liquid radioactive material. It protects persons from unnecessary radiation exposure by partially or totally blocking the radiation emissions from a vial or similar container holding a radiopharmaceutical or other radioactive material used in diagnostic or therapeutic procedures. It is made of lead (Pb) or lead-equivalent materials, the shielding properties may vary depending on the isotopes they are intended to be used with. Some include an opening that allows needle access to the vial contents and some are either totally transparent or include a window.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850014612078	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]